Comparison Between Efficacy of Inhaled VS Intravenous Tranexamic Acid for Hemoptysis
This will be a prospective comparative cohort study and will take place at the Ward II- Ojha Institute of Chest Diseases (OICD) ,Dow University of Health Sciences in Karachi.
It will be conducted over six months after obtaining necessary approvals. We will recruit 154 patients aged 18-60 years, regardless of gender, who will present with complain of hemoptysis. Patients will be selected through a non-probability consecutive sampling method, where each eligible patient will be approached for participation.
Participants will be randomly assigned to one of two groups using a lottery method:
- Group A will receive 500 mg of inhaled Tranexamic acid three times a day.
- Group B will receive 500 mg of intravenous Tranexamic acid three times a day.
Once patients give consent for participation, we will gather detailed medical history. Blood tests and X-rays will be done to assess each patient's health status.
We will then monitor the amount of blood expectorated after 30 minutes, 6 hours, 12 hours, and 24 hours post-administration. We will also observe any side effects from the treatment.
研究概览
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Sindh
-
Karachi、Sindh、巴基斯坦
- Ward-2 Ojha Institute of Chest Diseases (OICD), Dow University of Health Sciences
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult patients aged 18-60 years.
- Patients diagnosed with hemoptysis based on the defined operational definition.
- Patients who provide written informed consent to participate in the study.
Exclusion Criteria:
- Patients with known hypersensitivity to Tranexamic acid.
- Hemodynamically unstable patients.
- Patients requiring immediate interventional procedure or mechanical ventilation.
- Patients with active thromboembolic events (pulmonary embolism, deep vein thrombosis, ischemic stroke).
- Patients with a history of thromboembolic disease.
- Patients with disseminated intravascular coagulation (DIC) without heparin.
- Patients with severe renal impairment, gross upper urinary tract hematuria, recent vascular stent/graft, or subarachnoid hemorrhage.
- Pregnant and breastfeeding women.
- Patients who are not willing to participate in the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Inhaled Tranexamic Acid
|
Tranexamic acid 500 mg administered via inhaled route three times daily or intravenous route three times daily for management of hemoptysis |
|
实验性的：Intravenous Tranexamic Acid
|
Tranexamic acid 500 mg administered via inhaled route three times daily or intravenous route three times daily for management of hemoptysis |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Significant reduction in hemoptysis
大体时间：2 hours after drug administration
|
Proportion of patients achieving more than 50% reduction in hemoptysis blood volume after administration of Tranexamic Acid. |
2 hours after drug administration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Amount of hemoptysis reduction
大体时间：30 minutes, 6 hours, 12 hours, and 24 hours after drug administration
|
Change in amount of blood loss due to hemoptysis after treatment. |
30 minutes, 6 hours, 12 hours, and 24 hours after drug administration
|
|
Side effects of Tranexamic Acid
大体时间：Within 24 hours after drug administration
|
Presence of adverse effects after administration of Tranexamic Acid, including redness, burning, pain, swelling, or other reported side effects. |
Within 24 hours after drug administration
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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